Main Pancreatic Duct Diameter | NCT05385354

Studies
Main Pancreatic Duct Diameter

NCT05385354

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Nov 12, 2024Actual

Enrollment

115Actual

Phase

Not provided

Conditions

Pancreatic Duct Dilatation

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 3, 2022Actual

Primary Completion Date

Sep 15, 2024Actual

Completion Date

Oct 30, 2024Actual

First Submitted Date

May 6, 2022

First Submission Date that Met QC Criteria

May 17, 2022

First Posted Date

May 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2024

Last Update Posted Date

Nov 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Veit Phillip, Senior physician, head of clinical pancreatology, Technical University of MunichPrincipal Investigator

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound at four different parts:

Pancreatic head
Pancreatic neck
Pancreatic body
Pancreatic tail

Detailed Description

All patients without pancreatic or biliary disorders undergoing upper-GI endoscopic ultrasound (EUS) are eligible for the study.

The maximal diameter of the pancreatic duct will be measured by endoscopic ultrasound in millimeters at four different parts:

Pancreatic head
Pancreatic neck
Pancreatic body
Pancreatic tail

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal diameter of main pancreatic duct in millimeters	Measurements of main pancreatic duct at different sections of the pancreas	The measurement is performed once during endosonography.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract
Indication for EUS is undependent from the study
Written informed consent
Age ≥18 years

Exclusion Criteria:

Pancreatic diseases (chronic or acute pancreatitis, pancreatic tumor, pancreatic cyst, etc.)
Disorders of papilla duodeni major/minor (adenoma/carcinoma of papilla duodeni major or minor)
Biliary disorders (bile duct stones, cholangio carcinoma, cholangitis)
Elevated Bilirubin and/or Lipase

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing EUS for investigation of non-pancratic disease (e.g. subeptithelial tumor of the upper GI-tract

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic and Policlinik of Internal Medicine II		Munich	Bavaria	81675	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided